Health Canada Proposes Acetaminophen Labeling Changes

A new drug facts table would provide dosing instructions, warnings, and other safety information in a quick-reference, easy-to-read format.

Sep 21, 2015

Health Canada is proposing changes to the labeling standard for non-prescription acetaminophen products to help consumers use the products more safely. This is one of several steps Health Canada is taking to further minimize the risk of liver damage and improve acetaminophen safety; acetaminophen is an ingredient used in nearly 500 non-prescription and prescription products in Canada, including headache and pain remedies, allergy medicines, cold remedies, and narcotic pain relievers. Labels warnings already were strengthened by the agency in 2009.

The revised labeling standard is to help consumers identify products that contain the ingredient more easily and understand the liver risks it poses.The proposed changes include:

a prominent statement declaring the presence of acetaminophen

plainer language

a new drug facts table that provides dosing instructions, warnings, and other safety information in a quick-reference, easy-to-read format

stronger, clearer warnings about liver damage, including stronger warnings about use with alcohol

clearer, more prominent dosing instructions to help prevent the risk of accidental overdose, including statements that emphasize the maximum daily dose, dose intervals, and duration of us

This proposal follows a review of acetaminophen-related liver injuries.

Comments from the public, health professionals, patient groups, and other interested parties are due by Nov. 29. The draft standard is available here.

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